Updates | ClinRegs

Canada Profile Updated

Jul 26, 2024 - The Canada profile in ClinRegs has been reviewed and updated with the following information:Health Canada (HC) guidance on filing submissions electronically, including electronic Common Technical Document (eCTD) submission, non-eCTD electronic submission, and validation rules (See Submission ...

Bangladesh Profile Updated

Jul 16, 2024 - The Bangladesh profile in ClinRegs has been reviewed and updated with the following information:Updated Directorate General of Drug Administration (DGDA) guidelines on good clinical practice (GCP), including revisions related to the DGDA review of clinical trial protocols, oversight of institutional ...

Uganda Profile Updated with Revised NDA Service Delivery Timelines

Jul 10, 2024 - The Uganda profile in ClinRegs has been updated to include the National Drug Authority (NDA)'s revised service delivery timelines (See Timeline of Review).Sources Revised During this Update:(Webpage) National Drug Authority – Service Delivery Timelines (UGA-24) (Current ...

Australia Profile Updated with Revised TGA Fee Schedule

Jul 3, 2024 - The Australia profile in ClinRegs has been updated to include the Therapeutic Goods Administration (TGA)'s revised fee schedule, which took effect on July 1, 2024 (See Regulatory Fees).Sources Revised During this Update:(Guidance) Fees and Charges: Summary - From ...

Kenya Profile Updated

Jul 2, 2024 - The Kenya profile in ClinRegs has been reviewed and updated with the following information:Minor revisions to the Pharmacy and Poisons Board (PPB) guidance for the conduct of clinical trials, including an updated definition of investigational product, name change for the PPB clinical trial ...

India Profile Updated

Jun 21, 2024 - The India profile in ClinRegs has been reviewed and updated with the following information:2024 Central Drugs Standard Control Organization (CDSCO) Notice on the National Single Window System (NSWS) online portal launch and related resources (See Regulatory Fees, Submission ...

Vietnam Profile Updated

May 22, 2024 - The Vietnam profile in ClinRegs has been reviewed and updated with the following information: Updated documentation for the 2023-2028 term of the National Ethics Committee in Biomedical Research (See Ethics Committee and Scope of Review)Additional Ministry of Public Security personal data ...